Application 204748

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 150MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204748-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION			2017-10-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION	AP	2017-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204748-001	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE / INJECTION		2017-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204748-001	AP	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A204748-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204748-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204748-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204748-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204748-001	AP	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE TOPICAL	i3 Pharmaceuticals, LLC	8233eca5-d8bb-448d-9696-cb680da7a24f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	05a75685-0af5-407c-ac57-e380c882b49d	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	9dd8b4f9-9db8-4a16-abcd-bf32219e0301	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	3f7a3eaa-0f10-4cbe-b035-0796413308d5	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	25706fd8-d5e2-488b-9888-ee76d2686e19	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	576fbdf8-b44d-49bf-a569-601861cc402d	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindacin P	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	288371ef-96b6-4ce3-9be1-1d9d309b400c	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	NORTHSTAR RX LLC	62e1661f-1eab-4693-8cce-c22f572baa7f	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	27747e01-85eb-44de-a4a6-711a7799218a	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Corporation	1a42c3b2-90b5-4a78-9f18-fa789742b033	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	406534a6-2234-4735-ba8f-7de4c87592e6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Aurobindo Pharma Limited	d4b88e7b-acac-409a-8442-010ef84f66b9	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	461ab478-3cf6-4e9b-ba7d-0331b379cacf	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	44fa506b-90ac-42de-831b-5f3f1a500fc0	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	78832ac6-04c5-45e0-ae4d-f56d7920dda9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	5b8a6767-2d46-401c-9f85-d427dda9eff7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	c22fb382-afbc-4b2d-bdce-e97e21bddb23	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindacin ETZ	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	89fed26e-1cad-4c0b-8695-d6f3562ba8d5	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	34f7a271-c012-6463-e063-6394a90ad1ea	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52584-814	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-814	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-815	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-815	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-816	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-816	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-816	CLINDAMYCIN	CLINDAMYCIN	General Injectables and Vaccines, Inc.	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-814	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-815	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
67457-816	Clindamycin	Clindamycin	Mylan Institutional LLC	ANDA	Current
71872-7168	Clindamycin	Clindamycin	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50023	ORIG	2017-10-12